PMID- 31838180
OWN - NLM
STAT- MEDLINE
DCOM- 20201104
LR  - 20201104
IS  - 1872-7573 (Electronic)
IS  - 0378-8741 (Linking)
VI  - 250
DP  - 2020 Mar 25
TI  - Efficacy and safety of indigo naturalis ointment in Treating Atopic Dermatitis: A 
      randomized clinical trial.
PG  - 112477
LID - S0378-8741(19)32789-8 [pii]
LID - 10.1016/j.jep.2019.112477 [doi]
AB  - ETHNOPHARMACOLOGICAL RELEVANCE: Indigo naturalis, a herbal medicine with a 
      history of use dating back to ancient times, may be a good alternative topical 
      treatment for atopic dermatitis (AD). AIM OF THE STUDY: To provide empirical 
      evidence of the efficacy and safety of Indigo naturalis ointment in treating AD. 
      MATERIALS AND METHODS: In this randomized double-blind clinical trial, 
      participants aged 6 to 65 years with AD affecting less than 40% of their body 
      surface area (BSA) and an Investigator's Global Assessment (IGA) score of 2 to 4 
      were randomized (2:1) to receive either Lindioil ointment or a vehicle ointment 
      twice daily for 6 weeks. The primary endpoint was the percentage change in the 
      Eczema Area Severity Index (EASI) from baseline to week 6. Secondary endpoints 
      were as follows: EASI improvement >/=50%, 75%, and 90%; IGA score; BSA affected by 
      AD; pruritus severity; and Dermatology Life Quality Index. The safety assessment 
      included adverse events (AEs), laboratory tests, and physical examinations. 
      RESULTS: The Lindioil group (32 participants) and vehicle group (16 participants) 
      achieved mean percentage EASI reductions of 49.9% +/- 36.5% (95% CI 36.8%-63.1%) 
      and 19.6% +/- 52.2% (95% CI -8.2%-47.4%), respectively (P = 0.0235). The Lindioil 
      group also showed greater improvement in every secondary assessment category. No 
      significant AEs occurred. CONCLUSION: Indigo naturalis ointment is effective for 
      treating mild to severe AD topically, and appears to be safe. This is the first 
      clinical trial to provide evidence supporting topical indigo-based AD treatment. 
      ClinicalTrials.gov identifier: NCT02669888.
CI  - Copyright (c) 2019 Elsevier B.V. All rights reserved.
FAU - Lin, Yin-Ku
AU  - Lin YK
AD  - Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, 
      Keelung, 222, Maijin Road, Keelung, 20401, Taiwan; School of Traditional Chinese 
      Medicine, College of Medicine, Chang Gung University, 259, Wenhua 1st Rd, Guishan 
      Dist, Taoyuan, 33302, Taiwan. Electronic address: lin1266@cgmh.org.tw.
FAU - Chang, Shu-Han
AU  - Chang SH
AD  - Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, 
      Keelung, 222, Maijin Road, Keelung, 20401, Taiwan. Electronic address: 
      B9605005@cgmh.org.tw.
FAU - Yang, Chin-Yi
AU  - Yang CY
AD  - Department of Dermatology, Chang Gung Memorial Hospital, Linkou, 5, Fuxing St, 
      Guishan Dist, Taoyuan, 33305, Taiwan. Electronic address: 
      sophiachinyi@cgmh.org.tw.
FAU - See, Lai-Chu
AU  - See LC
AD  - Department of Public Health, And Biostatistics Core Laboratory, Molecular 
      Medicine Research Center, Chang Gung University, 259, Wenhua 1st Rd, Guishan 
      Dist, Taoyuan, 33302, Taiwan; Department of Rheumatology and Allergy and 
      Immunology, Chang Gung Memorial Hospital, Linkou, 5, Fuxing St, Guishan, Dist, 
      Taoyuan, 33305, Taiwan. Electronic address: lichu@mail.cgu.edu.tw.
FAU - Lee, Be-Han
AU  - Lee BH
AD  - Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, 
      Keelung, 222, Maijin Road, Keelung, 20401, Taiwan. Electronic address: 
      abbylee@cgmh.org.tw.
FAU - Shih, I-Hsin
AU  - Shih IH
AD  - Department of Dermatology, Chang Gung Memorial Hospital, Taipei, 199, Dunhua N. 
      Rd, Taipei, 10507, Taiwan. Electronic address: ma1606@cgmh.org.tw.
LA  - eng
SI  - ClinicalTrials.gov/NCT02669888
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20191212
PL  - Ireland
TA  - J Ethnopharmacol
JT  - Journal of ethnopharmacology
JID - 7903310
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drugs, Chinese Herbal)
RN  - R1R8QUL21Z (Qingdai compound)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Dermatitis, Atopic/*drug therapy/pathology
MH  - Dermatologic Agents/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drugs, Chinese Herbal/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Atopic dermatitis
OT  - EASI
OT  - Indigo naturalis
OT  - Indirubin
EDAT- 2019/12/16 06:00
MHDA- 2020/11/05 06:00
CRDT- 2019/12/16 06:00
PHST- 2019/07/19 00:00 [received]
PHST- 2019/11/26 00:00 [revised]
PHST- 2019/12/10 00:00 [accepted]
PHST- 2019/12/16 06:00 [pubmed]
PHST- 2020/11/05 06:00 [medline]
PHST- 2019/12/16 06:00 [entrez]
AID - S0378-8741(19)32789-8 [pii]
AID - 10.1016/j.jep.2019.112477 [doi]
PST - ppublish
SO  - J Ethnopharmacol. 2020 Mar 25;250:112477. doi: 10.1016/j.jep.2019.112477. Epub 
      2019 Dec 12.